Taiwan FDA registration bb7c8c0e86a1c21b5eb051ebdf149308
QUANTA Flash PR3 Calibrators
TW: 因諾瓦PR3化學冷光免疫分析法校正液
Taiwan·Risk Class 2·MD·INOVA DIAGNOSTICS, INC.·Registered May 07, 2015 – May 07, 2025ExpiredRegistration details
- Analysis ID
- bb7c8c0e86a1c21b5eb051ebdf149308
- License Form
- Ministry of Health Medical Device Import No. 027332
- Customs Code
- DHA05602733202
Company information
- Manufacturer
- INOVA DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, INC.
Product details
- Intended Use
- This product is used in the BIO-FLASH instrument to establish a reference point for the working curve when semi-quantitatively measuring PR3 IgG antibodies in human serological samples by QUANTA Flash PR3 chemical cold light immunoassay.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1150 calibrate
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- May 07, 2015
- Expiry Date
- May 07, 2025
About this record
Access comprehensive regulatory information for QUANTA Flash PR3 Calibrators in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number bb7c8c0e86a1c21b5eb051ebdf149308 and manufactured by INOVA DIAGNOSTICS, INC.. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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